Mometasone furoate effect on acute skin toxicity in breast cancer patients receiving radiotherapy: A phase III double-blind, randomized trial from the North Central Cancer Treatment Group N06C4

Robert C. Miller, David J. Schwartz, Jeff A Sloan, Patricia C. Griffin, Richard L. Deming, Jon C. Anders, Thomas J. Stoffel, Robert E. Haselow, Paul L. Schaefer, James D. Bearden, Pamela J. Atherton, Charles Lawrence Loprinzi, James A. Martenson

Research output: Contribution to journalArticle

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Abstract

Purpose: A two-arm, double-blind, randomized trial was performed to evaluate the effect of 0.1% mometasone furoate (MMF) on acute skin-related toxicity in patients undergoing breast or chest wall radiotherapy. Methods and Materials: Patients with ductal carcinoma in situ or invasive breast carcinoma who were undergoing external beam radiotherapy to the breast or chest wall were randomly assigned to apply 0.1% MMF or placebo cream daily. The primary study endpoint was the provider-assessed maximal grade of Common Terminology Criteria for Adverse Events, version 3.0, radiation dermatitis. The secondary endpoints included provider-assessed Common Terminology Criteria for Adverse Events Grade 3 or greater radiation dermatitis and adverse event monitoring. The patient-reported outcome measures included the Skindex-16, the Skin Toxicity Assessment Tool, a Symptom Experience Diary, and a quality-of-life self-assessment. An assessment was performed at baseline, weekly during radiotherapy, and for 2 weeks after radiotherapy. Results: A total of 176 patients were enrolled between September 21, 2007, and December 7, 2007. The provider-assessed primary endpoint showed no difference in the mean maximum grade of radiation dermatitis by treatment arm (1.2 for MMF vs. 1.3 for placebo; p = .18). Common Terminology Criteria for Adverse Events toxicity was greater in the placebo group (p = .04), primarily from pruritus. For the patient-reported outcome measures, the maximum Skindex-16 score for the MMF group showed less itching (p = .008), less irritation (p = .01), less symptom persistence or recurrence (p = .02), and less annoyance with skin problems (p = .04). The group's maximal Skin Toxicity Assessment Tool score showed less burning sensation (p = .02) and less itching (p = .002). Conclusion: Patients receiving daily MMF during radiotherapy might experience reduced acute skin toxicity compared with patients receiving placebo.

Original languageEnglish (US)
Pages (from-to)1460-1466
Number of pages7
JournalInternational Journal of Radiation Oncology Biology Physics
Volume79
Issue number5
DOIs
StatePublished - Apr 1 2011

Fingerprint

Mometasone Furoate
breast
toxicity
Radiodermatitis
radiation therapy
Radiotherapy
cancer
Breast Neoplasms
dermatitis
Pruritus
Skin
Placebos
Terminology
terminology
itching
Thoracic Wall
Neoplasms
grade
chest
Breast

Keywords

  • Breast neoplasms
  • Mometasone furoate
  • Radiotherapy
  • Skin manifestations
  • Toxicity

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Radiation
  • Cancer Research

Cite this

Mometasone furoate effect on acute skin toxicity in breast cancer patients receiving radiotherapy : A phase III double-blind, randomized trial from the North Central Cancer Treatment Group N06C4. / Miller, Robert C.; Schwartz, David J.; Sloan, Jeff A; Griffin, Patricia C.; Deming, Richard L.; Anders, Jon C.; Stoffel, Thomas J.; Haselow, Robert E.; Schaefer, Paul L.; Bearden, James D.; Atherton, Pamela J.; Loprinzi, Charles Lawrence; Martenson, James A.

In: International Journal of Radiation Oncology Biology Physics, Vol. 79, No. 5, 01.04.2011, p. 1460-1466.

Research output: Contribution to journalArticle

Miller, Robert C. ; Schwartz, David J. ; Sloan, Jeff A ; Griffin, Patricia C. ; Deming, Richard L. ; Anders, Jon C. ; Stoffel, Thomas J. ; Haselow, Robert E. ; Schaefer, Paul L. ; Bearden, James D. ; Atherton, Pamela J. ; Loprinzi, Charles Lawrence ; Martenson, James A. / Mometasone furoate effect on acute skin toxicity in breast cancer patients receiving radiotherapy : A phase III double-blind, randomized trial from the North Central Cancer Treatment Group N06C4. In: International Journal of Radiation Oncology Biology Physics. 2011 ; Vol. 79, No. 5. pp. 1460-1466.
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abstract = "Purpose: A two-arm, double-blind, randomized trial was performed to evaluate the effect of 0.1{\%} mometasone furoate (MMF) on acute skin-related toxicity in patients undergoing breast or chest wall radiotherapy. Methods and Materials: Patients with ductal carcinoma in situ or invasive breast carcinoma who were undergoing external beam radiotherapy to the breast or chest wall were randomly assigned to apply 0.1{\%} MMF or placebo cream daily. The primary study endpoint was the provider-assessed maximal grade of Common Terminology Criteria for Adverse Events, version 3.0, radiation dermatitis. The secondary endpoints included provider-assessed Common Terminology Criteria for Adverse Events Grade 3 or greater radiation dermatitis and adverse event monitoring. The patient-reported outcome measures included the Skindex-16, the Skin Toxicity Assessment Tool, a Symptom Experience Diary, and a quality-of-life self-assessment. An assessment was performed at baseline, weekly during radiotherapy, and for 2 weeks after radiotherapy. Results: A total of 176 patients were enrolled between September 21, 2007, and December 7, 2007. The provider-assessed primary endpoint showed no difference in the mean maximum grade of radiation dermatitis by treatment arm (1.2 for MMF vs. 1.3 for placebo; p = .18). Common Terminology Criteria for Adverse Events toxicity was greater in the placebo group (p = .04), primarily from pruritus. For the patient-reported outcome measures, the maximum Skindex-16 score for the MMF group showed less itching (p = .008), less irritation (p = .01), less symptom persistence or recurrence (p = .02), and less annoyance with skin problems (p = .04). The group's maximal Skin Toxicity Assessment Tool score showed less burning sensation (p = .02) and less itching (p = .002). Conclusion: Patients receiving daily MMF during radiotherapy might experience reduced acute skin toxicity compared with patients receiving placebo.",
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AU - Sloan, Jeff A

AU - Griffin, Patricia C.

AU - Deming, Richard L.

AU - Anders, Jon C.

AU - Stoffel, Thomas J.

AU - Haselow, Robert E.

AU - Schaefer, Paul L.

AU - Bearden, James D.

AU - Atherton, Pamela J.

AU - Loprinzi, Charles Lawrence

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N2 - Purpose: A two-arm, double-blind, randomized trial was performed to evaluate the effect of 0.1% mometasone furoate (MMF) on acute skin-related toxicity in patients undergoing breast or chest wall radiotherapy. Methods and Materials: Patients with ductal carcinoma in situ or invasive breast carcinoma who were undergoing external beam radiotherapy to the breast or chest wall were randomly assigned to apply 0.1% MMF or placebo cream daily. The primary study endpoint was the provider-assessed maximal grade of Common Terminology Criteria for Adverse Events, version 3.0, radiation dermatitis. The secondary endpoints included provider-assessed Common Terminology Criteria for Adverse Events Grade 3 or greater radiation dermatitis and adverse event monitoring. The patient-reported outcome measures included the Skindex-16, the Skin Toxicity Assessment Tool, a Symptom Experience Diary, and a quality-of-life self-assessment. An assessment was performed at baseline, weekly during radiotherapy, and for 2 weeks after radiotherapy. Results: A total of 176 patients were enrolled between September 21, 2007, and December 7, 2007. The provider-assessed primary endpoint showed no difference in the mean maximum grade of radiation dermatitis by treatment arm (1.2 for MMF vs. 1.3 for placebo; p = .18). Common Terminology Criteria for Adverse Events toxicity was greater in the placebo group (p = .04), primarily from pruritus. For the patient-reported outcome measures, the maximum Skindex-16 score for the MMF group showed less itching (p = .008), less irritation (p = .01), less symptom persistence or recurrence (p = .02), and less annoyance with skin problems (p = .04). The group's maximal Skin Toxicity Assessment Tool score showed less burning sensation (p = .02) and less itching (p = .002). Conclusion: Patients receiving daily MMF during radiotherapy might experience reduced acute skin toxicity compared with patients receiving placebo.

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